🏛️ Verified NIH Record • Updated 2024-12-18

Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial (NCT03150914)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: University of Cincinnati

🩺 Plain-English Summary (8th-Grade Level)

This is a study to determine if early, long-term low dose sirolimus is effective for preventing progression to more advanced stages.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (19 items).

Location: Stanford University — Palo Alto, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Existing or imminent (within 12-18 months) clinical indication for treatment with mTOR inhibitors, based on judgment of site investigator
  • DLCO \<60% predicted
  • Resting room air saturation \<90%
  • Exercise induced desaturation nadir on room air \< 85%
  • History of myocardial infarction, angina or stroke related to atherosclerosis
  • Pregnant, breast feeding, or plan to become pregnant in the next 2.5 years
  • Inadequate contraception
  • Significant hematologic, renal, metabolic or hepatic abnormality (i.e. transaminase levels \> three times the UL of normal range, HCT \< 30%, platelets \< 80,000/mm3, adjusted absolute neutrophil count \< 1,000/ mm3, total WBC \< 3,000/ mm3), creatinine \>2.5 mg/dl, uncontrolled hyperlipidemia
  • Acute or chronic infection, such as (nontuberculous mucobacteria or active hepatitis B or C infections)
  • Recent surgery (involving entry into a body cavity or requiring 3 or more sutures) within three weeks of initiation of study drug
  • Use of sirolimus, everolimus or investigational treatment for LAM within the 30 days prior to randomization

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

  • Stanford University — Palo Alto, California
  • National Jewish Hospital — Denver, Colorado
  • Emory University — Atlanta, Georgia
  • Loyola University — Chicago, Illinois
  • Brigham and Woman's Hospital — Boston, Massachusetts
  • University of Cincinnati — Cincinnati, Ohio
  • University of Pennsylvania — Philadelphia, Pennsylvania
  • Swedish Health — Seattle, Washington

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All LAM clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗